Observational Study to Determine How Physicians Make Treatment Decisions in Patients Treated With Tofacitinib for Moderate to Severe Active Rheumatoid Arthritis (ESCALATE-RA)

ESCALATE-RA A NON-INTERVENTIONAL STUDY OF CRITICAL FACTORS FOR ESCALATING DRUG TREATMENT IN PATIENTS TREATED WITH TOFACITINIB FOR MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS

This non-interventional study aims to identify key factors that are driving treatment decisions by rheumatologists in the treatment of rheumatoid arthritis (RA) patients starting treatment with Tofacitinib in a real world setting.

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Drug: Tofacitinib

• Study Type: Observational
• Enrollment (Actual): 1459

Contacts and Locations

Study Locations

• Germany
  • Altenburg, Germany, 04600
    • Private Practice Kupka
  • Altenholz, Germany, 24161
    • Private Practise Boehm
  • Amberg, Germany, 92224
    • Private Practice Marycz
  • Augsburg, Germany, 86157
    • Private Practice Fuchs
  • Bad Bramstedt, Germany, 24576
    • private practise Gause
  • Bad Kreuznach, Germany, 55543
    • ACURA Kliniken Rheinland-Pfalz AG
  • Bad Pyrmont, Germany, 31812
    • MFZ Medizinisches Forschungszentrum Weserbergland
  • Bamberg, Germany, 96047
    • Private Practice Manger
  • Bayreuth, Germany, 95444
    • Private Practice Ochs
  • Bayreuth, Germany, 95444
    • Private Practice Schmitt-Haendle
  • Bayreuth, Germany, 95444
    • Private Practice
  • Berlin, Germany, 12435
    • private practise Herzberg
  • Berlin, Germany, 10117
    • Ambulantes Gesundheitszentrum der Charité
  • Berlin, Germany, 10713
    • Private Practice Bozorg
  • Berlin, Germany, 12161
    • Private Practice Brandt-Juergens
  • Berlin, Germany, 12435
    • Privat Practice Remstedt
  • Berlin, Germany, 12555
    • Private Practice Seifert
  • Berlin, Germany, 13055
    • Private Practice Zinke
  • Berlin, Germany, 14129
    • Private Practice Thiele
  • Bernau, Germany, 16321
    • Immanuel Klinikum Bernau
  • Braunschweig, Germany, 38100
    • Private Practise
  • Burghausen, Germany, 84489
    • MED Bayern OST GmbH
  • Chemnitz, Germany, 09139
    • Private Practice Lorenz
  • Deggendorf, Germany, 94469
    • Private Practice Kirrstetter
  • Demmin, Germany, 17109
    • Kreiskranenhaus Demmin GmbH
  • Dortmund, Germany, 44263
    • Private Practice Menne
  • Dresden, Germany, 01097
    • Private Practice Luethke
  • Dresden, Germany, 01277
    • Private Practice Fischer
  • Eberswalde, Germany, 16225
    • private practise Pech
  • Ehringshausen, Germany, 35630
    • Private Practice Steinmueller
  • Elmshorn, Germany, 25335
    • Asklepios MVZ Nord SH GmbH, c/o AK St. Georg
  • Erfurt, Germany, 99096
    • Private Practice Kaestner
  • Erfurt, Germany, 99096
    • Private Practice Koch
  • Frankenberg/Sa., Germany, 09669
    • Private Practice Haeckel
  • Freiberg, Germany, 09599
    • Private Practice Mueller
  • Friedrichroda, Germany, 99894
    • SRH Krankenhaus Waltershausen-Friedrichroda GmbH
  • Germering, Germany, 82110
    • Private Practice Abahji
  • Gifhorn, Germany, 38518
    • Private Practice Sensse
  • Glaisin, Germany, 19288
    • Private Practice Holst
  • Goeppingen, Germany, 73033
    • Private Practice Zeh
  • Guestrow, Germany, 18273
    • Private Practice Semmler
  • Haldensleben, Germany, 39340
    • private practise Kühne
  • Halle, Germany, 06128
    • Private Practice Liebhaber
  • Hamburg, Germany, 22767
    • private practise Aries
  • Hamburg, Germany, 22415
    • Private Practice Dahmen
  • Hannover, Germany, 30161
    • Private Practice Stille
  • Heidelberg, Germany, 69120
    • private practise Heilig
  • Hohen Neuendorf, Germany, 16540
    • private practise Wernicke
  • Juelich, Germany, 52428
    • Private Practice Kremers
  • Kirchheim unter Teck, Germany, 73230
    • medius Kliniken gGmbH
  • Koeln, Germany, 50996
    • Private Practice Baerlecken
  • Langenau, Germany, 89129
    • Kreiskrankenhaus Langenau
  • Leipzig, Germany, 04109
    • Private Practice Hamann
  • Leipzig, Germany, 04129
    • Private Practice Schwarze
  • Magdeburg, Germany, 39104
    • private practise Sieburg
  • Magdeburg, Germany, 39104
    • Private Practice Kudela
  • Mansfeld, Germany, 06343
    • Private Practice Rossbach
  • Marktredwitz, Germany, 95615
    • Private Practice Harmuth
  • Muehlhausen, Germany, 99974
    • Private Practice Worsch
  • Muenchen, Germany, 81541
    • Private Practice Krueger
  • Muenster, Germany, 48143
    • Private Practice Raub
  • Naumburg (Saale), Germany, 06618
    • Praxis Dr.med. Holger Krauel Facharzt für Innere Medizin und Rheumatologie
  • Naunhof, Germany, 04683
    • Private Practice Berger
  • Neubrandenburg, Germany, 17033
    • Private Practise
  • Neuss, Germany, 41462
    • Private Practice Volberg
  • Nuernberg, Germany, 90443
    • MCN Medic Center Nuernberg GmbH
  • Passau, Germany, 94032
    • Private Practice Goettl
  • Pirna, Germany, 01796
    • Private Practice Graessler
  • Plauen, Germany, 08523
    • Private Practice Baumann
  • Puettlingen, Germany, 66346
    • Knappschaftsklinikum Soor, Klinik fuer Rheumatologie und Klinische Immunologie
  • Ratingen, Germany, 40878
    • Private Practice Wassenberg, Koehler, Weier
  • Rostock, Germany, 18059
    • Private Practice Richter
  • Saarbrücken, Germany, 66111
    • private practise Biewer
  • Schweinfurt, Germany, 97421
    • MVZ Dialysezentrum Schweinfurt
  • Schwerin, Germany, 19053
    • private practise Ständer
  • Schwerin, Germany, 19053
    • Private Practice Moebius
  • Schwerin, Germany, 19053
    • Private Practice
  • Seesen, Germany, 38723
    • Private Practice Melzer
  • Straubing, Germany, 94315
    • MVZ Klinikum Straubing
  • Templin, Germany, 17268
    • Private Practice
  • Torgelow, Germany, 17358
    • Private Practice Pyra
  • Tuebingen, Germany, 72072
    • Private Practice Haas
  • Uhlstaedt-Kirchhasel, Germany, 07407
    • Klinik an der Weissenburg GmbH
  • Ulm, Germany, 89073
    • Private Practice Rinaldi
  • Wiesbaden, Germany, 65189
    • Private Practice Woerth
  • Wuppertal, Germany, 42105
    • Klinikverbund St. Antonius und St. Josef GmbH
  • Wuppertal, Germany, 42285
    • Rheuma Praxis Barmen Dres. med. Demirel / Hruschka
  • Zwickau, Germany, 08056
    • Private Practice Fricke-Wagner
  • Zwiesel, Germany, 94227
    • Private Practice Alliger
  • Nordrhein-westfalen
    • Duesseldorf, Nordrhein-westfalen, Germany, 40237
      • Private Praxis
  • Sachsen
    • Zschopau, Sachsen, Germany, 09405
      • Private Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with confirmed diagnosis of rheumatoid arthritis who are eligible for treatment with Tofacitinb according to Summary of Product Characteristics (SmPC)

Description

Inclusion Criteria:

Patients aged ≥ 18 years

Confirmed Diagnosis of Rheumatoid Arthritis by rheumatologist

Patient is eligible for Tofacitinib treatment according to Summary of Product Characteristics (SmPC)

Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

Contraindications according to Xeljanz® SmPC

Receipt of any investigational drug within 3 months before study inclusion

Patients who have received any previous treatment with Tofacitinib or other JAK inhibitors

Patients who are investigational site staff members or patients who are Pfizer employees directly involved in the conduct of the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Escalations	Treatment escalations was defined as participants who switched to another disease modifying antirheumatic drug (DMARD) or combination of DMARDs when compared to the last visit. The following three types of escalations were reported: treatment termination, treatment step-up/switch and treatment step-down. Treatment termination was defined as the termination of a DMARD (or multiple when on combination therapy) without starting a new DMARD therapy. Treatment step-up/switch was defined as an increase from the current treatment regime towards e.g.a combination of DMARDs and treatment step-down, was defined as de-escalation from the current treatment regime, example (e.g.) from combination therapy to monotherapy. One participant can fall into more than 1 type of escalation.	From date of first prescription of tofacitinib up to 24 Months
Time to Treatment Escalation	Time to treatment escalation was defined as time in days from escalation visit date to next escalation visit date. The following three types of escalations were reported: treatment termination, treatment step-up/switch and treatment step-down. Treatment termination was defined as the termination of a DMARD (or multiple when on combination therapy) without starting a new DMARD therapy. Treatment step-up/switch was defined as an increase from the current treatment regime (monotherapy) towards a combination of DMARDs and treatment step-down, was defined as de-escalation from the current treatment regime, e.g. from combination therapy to monotherapy. Number of participants with total number of each type of treatment escalations during the study (step-up/switch, step-down, treatment termination along with all escalations) are reported in this outcome measure.	From date of first prescription of tofacitinib up to 24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Step Up Treatment Escalation	Time to first step-up treatment escalation was defined for participants who experienced a treatment step-up and was measured as date of first treatment step up escalation minus (-) date of first prescription of tofacitinib. Treatment step-up was defined as an increase from the current treatment regime (monotherapy) towards a combination of DMARDs.	From date of first tofacitinib prescription up to date of first step-up treatment escalation (maximum up to 24 months)
Number of Participants Achieving Low Disease Activity (LDA) as Assessed by Simplified Disease Activity Index (SDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24	SDAI was calculated using the following formula: SDAI = Tender Joint Count (TJC) (using 28 joints) + Swollen Joint Count (SJC) (using 28 joints) + Patient Global Assessment of Arthritis (PtGA) (0-10 centimetre [cm] scale) + Physician's Global Assessment of Arthritis (PhGA) (0-10 cm scale) + C-reactive protein (CRP) (milligram per decilitre [mg/dL]). TJC28 joints included shoulders, elbows, wrists, metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm visual analogue scale (VAS) scale (0 cm [very well] to 10 cm [worst], where higher scores indicated greater affliction due to disease activity). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of less than or equal to (<=11) indicates LDA.	Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving LDA as Assessed by Clinical Disease Activity Index (CDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24	CDAI was calculated using the following formula: CDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm). TJC28 joints included shoulders, elbows, wrists, MCP and proximal PIP joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm VAS scale (0 cm [very well] to 10 cm [worst], where higher scores indicated greater affliction due to disease activity). CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <= 10 indicates LDA.	Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving LDA Based on Disease Activity Score (DAS28-4) Erythrocyte Sedimentation Rate (ESR) at Months 3, 6, 9, 12, 15, 18, 21 and 24	DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56* square root of (TJC28) + 0.28* square root of (SJC28) + 0.70* natural log (ln) (ESR in [millimeter per hour [mm/ hour]) + 0.014*(PtGA in cm). PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 ESR <= 3.2 indicates LDA.	Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving LDA as Based on DAS28-4 C-Reactive Protein (CRP) at Months 3, 6, 9, 12, 15, 18, 21 and 24	DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56* square root of (TJC28) + 0.28* square root of (SJC28) + 0.36*ln (CRP in mg/l +1) + 0.014*(PtGA in mm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 CRP <= 3.2 indicates LDA.	Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving Remission as Assessed by American College of Rheumatology (ACR)-EULAR Boolean Remission Criteria at Months 3, 6, 9, 12, 15, 18, 21 and 24	ACR-EULAR Boolean remission criteria was defined as when participant had ACR remission =1 if; TJC28 <=1, SJC28 <=1, CRP <=1mg/dL and PtGA <= 2 cm on a 0 to 10 cm scale, where higher values indicate greater affection due to disease activity.	Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving Remission as Assessed by SDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24	SDAI was calculated using the following formula: SDAI = (TJC28) + (SJC28) + (PtGA in cm) + (PhGA in cm) + (CRP in mg/dL). TJC28 joints included shoulders, elbows, wrists, MCP and PIP joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm VAS scale (0 cm [very well] to 10 cm [worst], where higher scores indicated greater affliction due to disease activity). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of <=3.3 indicates remission.	Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving Remission as Assessed by CDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24	CDAI was calculated using the following formula: CDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm). TJC28 joints included shoulders, elbows, wrists, MCP and proximal PIP joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm VAS scale (0 cm [very well] to 10 cm [worst], where higher scores indicated greater affliction due to disease activity). CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <=2.8 indicates remission.	Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving Remission as Assessed by DAS-28 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24	DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56*square root of (TJC28) + 0.28*square root of (SJC28) + 0.70*In (ESR in mm/ hour) + 0.014*PtGA in cm. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 ESR score of <2.6 indicates remission.	Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving Remission as Assessed by DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24	DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56*square root of (TJC28) + 0.28*square root of (SJC28) + 0.36*ln (CRP in mg/l +1) + 0.014*(PtGA in cm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 CRP score of <2.6 indicates remission.	Months 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in DAS28-4 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24	DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56*square root of (TJC28) + 0.28*square root of (SJC28) + 0.70*In (ESR in mm/ hour) + 0.014*PtGA in cm. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity.	Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24	DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56*square root of(TJC28) + 0.28*square root of(SJC28) + 0.36*ln (CRP in mg/l +1) + 0.014*(PtGA in cm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity.	Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in Duration of Morning Stiffness at Months 3, 6, 9, 12, 15, 18, 21 and 24	The duration of morning stiffness was determined by asking the following questions: "When you wake up in the morning, do you currently suffer from morning stiffness?" "How long does the morning stiffness last from the time you wake up?". The change from baseline in duration of morning stiffness was calculated as: morning stiffness at time point -morning stiffness at baseline.	Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in the Functional Ability Questionnaire Hannover (FFbH) at Months 3, 6, 9, 12, 15, 18, 21 and 24	The FFbH for RA is a German short questionnaire for the assessment of patientive functional capacity in the context of basic everyday activities (range: 0-100% functional capacity, where higher percentage indicates more capacity for everyday activities). The FFbH questionnaire consisted of 18 questions with 3 possible responses (Yes; Yes, but with effort; No or only with outside help). The total score was the sum of the scores of all 18 questions, where for each question (Yes = 2 points; Yes, but with effort = 1 point; No or only with outside help = 0 points).The functional capacity (%) is calculated by (total score*100) divided by (2*number of valid responses). The change from baseline was calculated at each time point as functional capacity at timepoint - functional capacity at baseline.	Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving Functional Remission in FFbH at Months 3, 6, 9, 12, 15, 18, 21 and 24	The FFbH for RA is a German short questionnaire for the assessment of patientive functional capacity in the context of basic everyday activities (range: 0-100% functional capacity, where higher percentage indicates more capacity for everyday activities). The FFbH questionnaire consisted of 18 questions with 3 possible responses (Yes; Yes, but with effort; No or only with outside help). The total score was the sum of the scores of all 18 questions, where for each question (Yes = 2 points; Yes, but with effort = 1 point; No or only with outside help = 0 points). The functional capacity [%] is calculated by (total score*100)/ (2*number of valid responses). Functional remission in FFbH was defined as functional capacity > 83 %.	Months 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in European Quality of Life (EuroQoL) Group EuroQoL- 5 Dimensions- 3 Levels (EQ-5D-3L) Total Scores at Months 3, 6, 9, 12, 15, 18, 21 and 24	The EQ-5D-3L is a standardised instrument used to measure quality of life. It is based on five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem. Scoring formula developed by EuroQol Group (German weights) assigns a utility value for each domain in the profile. Score was transformed and results in a total score range of 0.05 to 1.00; higher scores indicating a better health state.	Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale at Months 3, 6, 9, 12, 15, 18, 21 and 24	The FACIT-F Scale is a participant completed questionnaire consisting of 13 items that assess fatigue. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Instrument scoring yielded a range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue).	Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
Mean Number of Days of Drug Survival at Months 12 and 24	Drug survival was assessed using Kaplan-Meier methodology. For participants who terminated tofacitinib, the drug survival status was recorded as (status = 1 and time = termination date tofacitinib - date of initiation on tofacitinib) and for participants who do not terminate tofacitinib (status = 0 and time = date of final visit - date of initiation on tofacitinib.	At 12 and 24 months
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24	Satisfaction with treatment was assessed on a 5-point Likert scale (where 0 = extremely dissatisfied, 1= dissatisfied, 2 = neither satisfied nor dissatisfied, 3 = satisfied and 4 = extremely satisfied) in response to the question "How satisfied are you with the drugs that you have received for your arthritis since your last visit?".	Months 3, 6, 9, 12, 15, 18, 21 and 24

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2017
• Primary Completion (Actual): July 17, 2023
• Study Completion (Actual): July 17, 2023

Study Registration Dates

• First Submitted: December 7, 2017
• First Submitted That Met QC Criteria: December 21, 2017
• First Posted (Actual): January 2, 2018

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Janus Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: A3921302; ESCALATE-RA (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.